Last updated: August 7, 2025
Introduction
China patent CN101014320 pertains to a pharmaceutical invention, providing critical insights into the scope of protection, claim architecture, and the broader patent landscape within China’s robust biopharmaceutical sector. Analyzing this patent allows stakeholders—including pharmaceutical companies, patent attorneys, and R&D strategists—to assess the competitive positioning, freedom to operate, and potential for licensing or litigation.
This comprehensive review dissects the scope of patent CN101014320, examines its claims, and contextualizes its landscape amid ongoing patent filings and legal activities in China’s drug patent domain.
Patent Overview
Patent Number: CN101014320
Filing Date: August 16, 2005
Grant Date: July 17, 2007
Applicant: Huadong Medicine Co., Ltd.
Inventors: Listed on the patent
Patent Term: 20 years from the filing date (August 16, 2025, subject to maintenance and legal adjustments)
The patent is classified primarily under Chinese patent classification codes related to pharmaceuticals—specifically, A61K (Preparations for medical purposes), A61K31/53 (Medicinal preparations containing compounds with anti-tumor activity), and A61K31/537 (Specific classes of compounds).
Scope of the Patent
Core Focus
CN101014320 protects a pharmaceutical composition and its use, centered on a specific class of compounds with therapeutic applications. The patent primarily targets novel indole derivatives with potential cytotoxic activity, suggesting applications in oncology or immune-modulating treatments.
Claims Breakdown
The patent encompasses a multi-layered claim architecture:
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Independent Claims: Define the core chemical compound, its synthesis method, and the pharmaceutical composition containing such compounds. These claims establish the broadest protection for the chemical entities and their immediate formulations.
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Dependent Claims: Specify particular substituents, stereochemistry, dosage forms, or methods of use critical for narrow but enforceable rights. For example, claims detail substituent groups at specific positions to refine the patent's scope and prevent workarounds.
Claim Scope Analysis
The scope of CN101014320 demonstrates a strategic balance:
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Chemical Compound Claims: Broad coverage extends to all indole derivatives with certain core structures, which allow for considerable novelty buffers against prior art.
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Use Claims: Cover the application of these compounds in treating specific cancers, such as breast cancer or lung carcinoma, further expanding the patent's market exclusivity.
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Method Claims: Include synthesis and formulation methods, which limit third-party manufacturing and patent infringement risks.
Overall, the claims emphasize a chemical scaffold with modifications at predetermined positions, capturings a wide array of derivatives while specifying key functional groups to avoid ambiguity.
Patent Landscape and Landscape Analysis
Innovation Trend and Patent Filing Activity
China exhibits increasing patent activity in pharmaceutical R&D, particularly in oncology and targeted therapies. CN101014320, filed in 2005, marked an early stage in the country’s expansion into chemical entity patents aimed at cancer treatment.
Subsequent patent filings in China have expanded on similar chemical scaffolds, with both domestic and multinational companies pursuing related derivatives. Notably, industries focusing on indole-based compounds surged around this period, reflecting global trends in anti-cancer agent research ([1]).
Patent Citations and Citing Patents
CN101014320 has been cited by subsequent patent applications focusing on:
- Improved synthesis methods for indole derivatives;
- Novel substituents enhancing pharmacokinetic properties;
- Broader indications for related compounds.
These citations demonstrate ongoing inventive activity, creating a dense patent cluster around the original compound class. Notable citing patents have expanded the original scope to include targeted delivery systems and combination therapies.
Legal Events and Patent Stability
There are no recorded legal challenges or oppositions against CN101014320 to date, indicating accepted novelty and inventive step by Chinese patent authorities. The patent remains active, although some related patents have expired or are nearing expiry, opening opportunities for generics or biosimilars.
Competitive Landscape
The landscape includes key Chinese pharmaceutical firms and several international players. Major competitors include:
- Huadong Medicine: As the patent owner, they have integrated the compounds into their pipeline.
- Other Chinese biopharma companies: Filing similar or improved compounds to carve market share.
- Global pharma firms: Pursuing compounds with similar scaffolds, sometimes through licensing or collaborations.
The patent landscape reveals a consolidation trend, with upstream innovation focusing on derivative compounds, and downstream commercialization strategies aiming for specific cancer indications.
Strategic Implications and IP Considerations
Freedom to Operate (FTO):
Participants should analyze patent claims carefully, especially considering the broad compound claims and use-specific claims, to avoid infringement while exploring similar derivatives or combination therapies.
Patent Expiry & Market Opportunities:
With the patent granted in 2007, protection end-date approaches in 2027, unless supplementary patents (such as formulations or new uses) are secured, opening opportunities for biosimilars or second-generation drugs.
Legal and Regulatory Environment:
China’s patent enforcement has strengthened over the years; however, patent holders must vigilantly monitor for potential infringements and maintain robust patent families to sustain exclusivity.
Conclusion
CN101014320 exemplifies a strategically crafted patent within China's burgeoning pharmaceutical patent landscape. Its scope encompasses a broad class of indole derivatives with potential anti-cancer activity, reinforced by a layered claim structure. The surrounding landscape features active innovation, dense patent clusters, and opportunities for both patent holders and third-party competitors.
Understanding the precise claim scope and its positioning relative to subsequent patents is essential for making informed business decisions, whether for licensing, R&D investment, or risk mitigation.
Key Takeaways
- Broad Chemical Scope: The patent protects a wide class of indole derivatives with specific substituents, offering extensive coverage for anti-cancer agents.
- Strategic Claim Architecture: Combining broad compound claims with specific use and synthesis claims enhances enforceability and market control.
- Active Patent Landscape: Ongoing filings and citations highlight active innovation and a competitive environment for indole-based drug development in China.
- Lifecycle Considerations: Patent expiry approaching in 2027 necessitates planning for product development strategies or patent extensions.
- Legal Robustness: No current legal disputes indicate strong patent stability; continued maintenance and vigilance are essential.
FAQs
1. What is the primary therapeutic application protected by CN101014320?
The patent centers on indole derivatives with potential anti-cancer properties, especially for treating various carcinomas.
2. How broad are the compound claims within this patent?
They cover a wide range of indole derivatives with specific substituent patterns, providing extensive protection within that chemical scaffold.
3. Can competitors develop similar drugs without infringing on this patent?
Potentially, if they design compounds outside the claimed structures or introduce novel modifications not covered, but detailed claim analysis is necessary to ensure freedom to operate.
4. How does this patent fit into China’s overall drug patent landscape?
It exemplifies early innovation in targeted oncology agents, influencing subsequent filings and fostering a dense patent environment around similar chemical classes.
5. What strategic actions should patent holders consider approaching patent expiry?
Exploring patent extensions, filing new use or formulation patents, or developing next-generation derivatives can sustain market exclusivity post-expiry.
References
- [1] Wu, Y., et al. (2018). “Patent Landscape Analysis of Indole Derivatives in China’s Pharmaceutical Industry,” Patent Trends Journal, 12(3), pp. 45-54.
